FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: CryoPatch SG Pulmonary Hemi-Artery Patch
- Recall number
- Z-1219-2019
- Recalling firm
- CryoLife, Inc.
- Product
- CryoPatch SG Pulmonary Hemi-Artery Patch
- Status
- Terminated
- Initiated
- 2016-11-21
- Posted
- not on file
- Terminated
- 2019-09-24
- Reason
- The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- The firm sent the physician a letter on 11/21/2016.
- Quantity
- 1
- Distribution
- Product was shipped to Texas
- Lot, serial or model codes
- Model #: SGPHOO Serial #10685466
- 510(k) numbers
- ["K091626"]
- PMA numbers
- not on file
- Product code
- DXZ
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28